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TubeClear Receives FDA Clearance for New GJ-Specific Clearing Stem Model

TubeClear Receives FDA Clearance for New GJ-Specific Clearing Stem Model

BELLEFONTE, PA – Actuated Medical, Inc. (AMI) recently received its sixth Food and Drug Administration (FDA) 510(k) clearance for the TubeClear® system. Clearance number K200646 introduces a Clearing Stem model that is compatible with select gastro-jejunostomy (GJ) feeding tubes.

These complex dual lumen feeding tubes are often expensive and require surgery to place. When a clogged feeding tube of any type cannot be cleared, it requires replacement. The new TubeClear GJ-1422 Clearing Stem offers a mechanical option for clinicians to keep these expensive GJ tubes clear and avoid an unnecessary procedure to replace the tube. The GJ-1422 Clearing Stem is designed to work with MIC*, MIC-KEY* (Avanos Medical, Inc., Alpharetta, GA) and G-Jet® (Applied Medical Technology (AMT), Brecksville, OH) GJ feeding tubes that are 14-22 French diameter and have a jejunal length of 15-45 centimeters.

“Clogging in GJ tubes is one of the most common complaints we hear from clinicians and patients alike,” said AMI president and chief executive officer Maureen L. Mulvihill, PhD. “Being able to deliver a Clearing Stem that is compatible with our existing TubeClear system as well as GJ feeding tubes is an exciting opportunity for AMI to support vulnerable patients and improve their outcomes.”

The TubeClear system is an FDA cleared medical device that uses patented mechanical motion technology to maintain flow and clear clogs in most feeding and decompression tubes while the tube remains in the patient and works at bedside. Keeping these tubes clear prevents interruptions to feeding and medication delivery, allowing clinicians to maintain their focus on improving patient care and reducing healthcare cost associated with tube replacement. The system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed, and manufactured by AMI in Bellefonte, PA. The new GJ Clearing Stem is slated to be available for sale in clinical settings in early 2021.

 

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About Actuated Medical, Inc.

Actuated Medical develops medical devices that integrate electronically controlled motion technologies that improve patient outcomes and reduce healthcare costs. Their development process focuses on intellectual property, regulatory, and reimbursement strategies to decrease commercialization risk and attract medical device technology licensing partnerships. Their devices solve unmet clinical needs in target markets (e.g., GI, oncology, critical care and pediatrics). Actuated Medical a certified women-owned business located in Bellefonte, PA and is ISO 13485:2016 certified.

For more information, please visit http://www.actuatedmedical.com

 

The Impact of Clogged Feeding Tubes

The Impact of Clogged Feeding Tubes

“This could change the world!” exclaimed a young man observing a product demonstration. He had been tube fed his whole life and seeing the TubeClear System power through a simulated clog in a clear feeding tube captured his attention.

Exhibiting the TubeClear System at the Oley Foundation’s Annual Conference was a new experience for the Actuated Medical team. While many conferences and trade shows target a specific audience, this one was a little different. A non-profit organization providing support to patients on total parenteral nutrition (TPN) or enteral nutrition (EN) and their families, the Oley Foundation invites everyone associated with these two nutritional health requirements to its Annual Conference. Attendees ranged from gastroenterologists and dietitians to the tube-fed patients themselves, allowing a glimpse at the bigger picture of EN and the impact of clogs. These are patients who rely on TPN or EN for their nutrition, medication, and hydration needs as they battle numerous conditions. For them, that tube is their lifeline – their world.

It was a humbling experience, to say the least. These individuals know feeding tubes, and they know clogs. In literature, clogs occur as often as 35% of the time.[i] It seems like a small problem. But for the individual who experiences one, it’s a problem that can grow and affect many aspects of their lives.

Clogs Take Time

Rather, they steal time. A clogged feeding tube interrupts enteral therapy, preventing nutrition, medication, and hydration from being delivered as scheduled. In the hospital setting, this caloric deficit increases their length of stay by eight days.[ii]

Current recommended solutions for removing clogs take time as well. Flushing with water is generally regarded as the standard of care; however, it takes an average of 110 minutes to work while commercial enzyme declogging products such as Clog Zapper take more than 120.[iii] In addition, water is only 20% effective while enzymes are 33% effective at dissolving the obstruction.[iv]

When a feeding tube occlusion cannot be cleared, it must be replaced. Depending on the type of tube, this can require an invasive procedure performed by a specialist as they are available. Some patients must travel long distances for these procedures, with weekends and holidays affecting availability. The patient may have to wait hours or even days before returning to their enteral therapy routines.

Clogs Add Risks

To restore patency for EN to resume, clinicians and patients alike try many possibilities. One of the most common “solutions” is soda, in spite of lack of evidence to support its efficacy. In fact, the acidic nature of sodas and juices can react with enteral formula to make the occlusion worse or create future clogs.[i] It may also lead to damage of the feeding tube itself.[i]

In desperation, foreign objects may be inserted that are not designed for feeding tubes, creating risk of damaging or perforating the tube.

Replacing a feeding tube due to a clog brings the risks associated with tube placement. Nasal feeding tubes have been misplaced into the lungs[v] and even the brain[vi]. Only between 80 and 85% of Tube insertions are successful on the first try, risking complications and multiple radiographs for re-insertion.[vii] Misplacement is such a large concern for pediatric patients that the American Society for Parenteral and Enteral Nutrition (ASPEN) launched the New Opportunities for Verification of Enteral Tube Location (NOVEL) Project.[viii]

“Keeping the feeding tube clear is important for patient safety,” said Beth Lyman, RN, MSN, CNSC, retired Senior Program Coordinator for the Nutrition Support Team at Children’s Mercy Hospital. “If you have to replace the feeding tube, you get those misplacement risks all over again.”

Misplacement isn’t the only risk associated with replacing a feeding tube. Patient transportation, whether from outside the hospital or within, adds risks to that patient’s health and safety.[ix] Entering a hospital also increases a patient’s risk of infection.[x]

The Cost of Clogs

There are a number of different costs associated with clogged feeding tubes. Replacing a feeding tube includes the cost of the hardware as well as the procedure. These costs can range from $200 to $1,000 depending on the type of feeding tube.[xi] For patients outside the hospital, there might be a transportation cost if they require an ambulance.

Another cost to consider is to the patient’s psychological well-being. If the patient is malnourished and dehydrated as a result of the clogged feeding tube, they may experience feelings of apathy, depression, fatigue, and loss of morale.[xii]

Replacement of a feeding tube can also be scary. “It was a traumatic experience for my son,” said one parent attending the Oley Annual Conference. Another described the experience of a nasogastric placement as “feeling like you’re drowning.”

Clogged feeding tubes are a common problem, and they can occur for several different reasons. Improperly crushed medication, mixing formula and medication, medication interactions, checking gastric fluids, and slow infusion rates are just some of the reasons for clogging.[xiii] Adequate water flushing can help prevent them, but it’s not enough. Feeding tube clogs are often treated as a minor technical issue; however, for the patients relying on these tubes to provide enteral therapy (e.g., medication, nutrition and hydration), reducing the impact of clogs means better outcomes.

References:

[i] Dandeles, Lauren M. and Lodolee, Amy E. “Efficacy of Agents to Prevent and Treat Enteral Feeding Tube Clogs.” The Annals of Pharmacotherapy, 2011; 45:676-680.

[ii] Peev, M. P., Yeh, D. D., Quraishi, S. A., Osler, P., Chang, Y., Gillis, E., Albano, C. E., Darak, S. and Velmahos, G. C. “Causes and Consequences of Interrupted Enteral Nutrition.” Journal of Parenteral and Enteral Nutrition, 2015; 39:21-27.

[iii] Unpublished data by Garrison, C.M.

[iv] Garrison, C. M., “Enteral Feeding Tube Clogging: What Are the Causes and What Are the Answers? A Bench Top Analysis.” Nutrition in Clinical Practice, 2018; 33(1):147-150.

[v] de Aguilar-Nascimento, J.E. and Kudsk, J.A.. “Clinical costs of feeding tube placement.” Journal of Parenteral and Enteral Nutrition, 2007; 31(4):269-273.

[vi] Hassan A. The inadvertent intracranial introduction of nasogastric tube: The lesson learned the hard way. Saudi J Health Sci, 2016;5:145-7

[vii] Gubler, C. et al. “Bedside sonographic control for positioning enteral feeding tubes: a controlled study in intensive care unit patients.” Endoscopy, 2006; 38(2):1256-1260.

[viii] American Society for Parenteral and Enteral Nutrition (ASPEN). http://www.nutritioncare.org/NOVEL/. Accessed 25 June 2019.

[ix] Knight, P. H., Maheshwari, N., Hussain, J., Scholl, M., Hughes, M., Papadimo, T.J., Guo, W.A., Cipolla, J., Stawicki, S.P., Latchana, N. “Complications During Intrahospital Transport of Critically Ill Patients: Focus on risk Identification and Prevention.” International Journal of Critical Illness and Injury Science, 2015; 5(4):256-264.

[x] Office of Disease Prevention and Health Promotion. https://health.gov/hcq/prevent-hai.asp. Accessed 25 June 2019.

[xi] Escuro, A., Rath, M., Strauser, C. “Evaluation of a tube declogging system in clearing occluded small bore nasoenteric feeding tubes.” Oral Presentation-Nutrition Science & Practice Conference 2019, Abstract # M8.

Lord, LM. “Maintaining Hydration and Tube Patency in Enteral Tube Feedings.” Safe Practices in Patient Care, 2001.

Cresci, G. and Martindale, R.  “Bedside Placement of Small Bowel Feeding Tubes in Hospitalized Patients: A New Role for the Dietitian.” Nutrition, Oct; 19 (10):843-6 (2003).

[xii] Lord, L.M. “Enteral Access Devices: Types, Function, Care, and Challenges.” Nutrition in Clinical Practice, 2016; 33(1): 16-38.

[xiii] Lord, L.M. “Restoring and Maintaining Patency of Enteral Feeding Tubes.” Nutrition in Clinical Practice, 2003; 18(5):422-426.

Partnership with PSU Nursing School

Actuated Medical’s partnership with Penn State’s College of nursing helped speed TubeClear to market and ensure clinician adoption. Janice Penrod, director of the Center for Nursing Research at Penn State’s College of Nursing commented, “It’s a perfect case of integrating engineering with clinical nursing to produce medical devices that meet patient needs. The College of Nursing was involved from initial concept through development and testing, then creating instructional materials.”